On December 12th, 2013 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released its new report – Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. As a part of its cross-contextual and cross-modality analysis, the Bioethics Commission reviewed the work of a number of national and international panels and professional groups’ guidelines and recommendations on the issue. To provide rhetorical clarity and precision, the Bioethics Commission also presented a definitional taxonomy that builds upon the work of scholars in the field, including Dr. Erik Parens, who presented to the Commission regarding the definition of incidental findings.
The Bioethics Commission defined five categories of findings that, elucidated below, can result from medical tests and procedures, and noted that it is important to distinguish between each (a table of these findings can be found on page 27 of the report).
Under the Bioethics Commission’s taxonomy, primary findings are findings that are the principal purpose for the practitioner conducting the test. For example, when a clinician orders a test to measure a patient’s cholesterol, and discovers that the patient has high cholesterol, that finding is a primary finding.
A practitioner also can discover a range of findings that are outside the scope of the primary purpose of the test – incidental findings. The Bioethics Commission further divided the term incidental findings into two categories: anticipatable incidental findings and unanticipatable incidental findings. Anticipatable incidental findings are known possible results of a particular test or procedure. These include well-documented findings, such as the discovery of a lung nodule when conducting a chest X-ray to diagnose pneumonia, or mismatched paternity when conducting blood typing for organ donation. However, anticipatable incidental findings need not be common or even expected in this particular case; they just need to be known to be possible.
Unanticipatable incidental findings, on the other hand, are findings that cannot be expected or anticipated at the time the test is conducted, but arise nonetheless. For example, when conducting genomic analysis, a variant might be discovered that has no current significance, but that future research correlates to a serious disease
Secondary findings are findings which are not the primary purpose of the test but that the practitioner seeks nonetheless. There has been discussion amongst scholars and practitioners regarding whether certain anticipatable incidental findings pose such significant health risk that practitioners have an ethical duty to seek and return them as secondary findings. For example, the American College of Medical Genetics and Genomics (ACMG) has published a list of genetic variants that it believes to be clinically significant and actionable. ACMG recommended that laboratories seek and report these variants as secondary findings whenever they conduct clinical exome or genome sequencing. The Bioethics Commission has recommended that more practitioners develop lists of such significant and actionable findings, so that, instead of stumbling upon incidental findings, practitioners can plan for anticipatable incidental findings, and perhaps actively seek them as secondary findings.
Finally, the Bioethics Commission also outlines discovery findings. These are findings that result from a broad test conducted to discover anything of interest. For example, some DTC companies are offering full-body scans that purport to seek and report anything of interest discovered in the entire body. None of the findings resulting from such a broad test could be considered incidental, but discovery findings can nonetheless cause anxiety and distress for individuals. Although Anticipate and Communicate does not focus specifically on these discovery findings because of their broad goal, many of the concepts described in the report could also aid in their ethical management.
This additional definitional clarity will provide scholars with a more precise taxonomy for discussing and evaluating the ethical management of medical findings.